Actinic KeratosisNCT02090465
Assessment of Treatment Success and Quality of Life in Patients With Actinic Keratoses Under Therapy With Ingenol Mebutate in a Period of 8 Weeks
An observational study of Actinic Keratosis, run by LEO Pharma at 1 site in Germany.
Trial summary
Assessment of treatment success and quality of life in patients with actinic keratoses under therapy with Ingenol Mebutate (Picato) in a period of 8 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Actinic Keratosis
- What is being tested?
- Ingenol Mebutate
- How many people
- 840 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2013to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with actinic keratosis contacting their dermatologist
Who may be able to join
- Non-hyperkeratotic, non-hypertrophic actinic keratoses where treatment with Picato® is indicated and the treatment is intended by physicians.
Who cannot join
- Preceding use of Picato® on the area planned for treatment
- Any other specific local treatment of actinic keratoses on the area planned for treatment during the last 8 weeks
- Melanoma, squamous cell carcinoma or spinalioma on the area planned for treatment
- Open wounds on the area planned for treatment
- Contraindications according to prescribing information
Trial locations and contacts
1 site in 1 country.
Germany1 site
Universitätsklinikum Heidelberg/Klinische Sozialmedizin
Heidelberg, D-69115
About this study
Official title: Assessment of Treatment Success and Quality of Life in Patients With Actinic Keratoses Under Therapy With Ingenol Mebutate (Picato) in a Period of 8 Weeks.
Assessment of treatment success and quality of life in patients with actinic keratoses under therapy with Ingenol Mebutate (Picato) in a period of 8 weeks.
Read the detailed description
Non-interventional (observational) study (NIS), non-controlled, prospective cohort study.
- Conditions
- Actinic Keratosis
- Being tested
- Ingenol Mebutate
- Keywords
- Actinic Keratosis
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ingenol MebutateDrug
Also called Picato®
No intervention: observation of routine use of Picato®
| Study group | Role | What they receive |
|---|---|---|
| all eligible patients | Treatment with Picato according to Summary of Product Characteristics (SmPC) Receives: Drug: Ingenol Mebutate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Actinic keratosis
Documentation of the course of actinic keratoses and skin findings during ambulant routine use of Picato®
Measured: 8 weeks
Skindex-16
Patient' s quality of life during ambulant routine use of Picato®
Measured: 8 weeks
Dosage of Picato®
Prescribed and applied dosages and adherence during ambulant routine use of Picato®
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2014 (estimated)
- Study startJul 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Actinic KeratosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 840 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Diepgen, Prof. Dr. med., Principal investigator, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02090465
- Sponsor's protocol ID
- DE-Picato NIS-2013
- Status last verified
- Dec 2019
- First submitted
- 12 Mar 2014
- Last updated
- 17 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Treatment Success and Quality of Life in Patients With Actinic Keratoses Under Therapy With Ingenol Mebutate (Picato) in a Period of 8 Weeks.
- ClinicalTrials.gov ID
- NCT02090465
- Acronym / sponsor ID
- DE-Picato NIS-2013
- Conditions
- Actinic Keratosis
- Keywords
- Actinic Keratosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 840 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- Jul 2013 (actual)
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 18 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Assessment of treatment success and quality of life in patients with actinic keratoses under therapy with Ingenol Mebutate (Picato) in a period of 8 weeks.
Detailed description
Non-interventional (observational) study (NIS), non-controlled, prospective cohort study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| all eligible patients | – | Drug: Ingenol MebutateTreatment with Picato according to Summary of Product Characteristics (SmPC) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with actinic keratosis contacting their dermatologist
Key inclusion criteria (1 listed)
- Non-hyperkeratotic, non-hypertrophic actinic keratoses where treatment with Picato® is indicated and the treatment is intended by physicians.
Key exclusion criteria (5 listed)
- Preceding use of Picato® on the area planned for treatment
- Any other specific local treatment of actinic keratoses on the area planned for treatment during the last 8 weeks
- Melanoma, squamous cell carcinoma or spinalioma on the area planned for treatment
- Open wounds on the area planned for treatment
- Contraindications according to prescribing information
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ingenol MebutateAlso: Picato®No intervention: observation of routine use of Picato® | Drug | all eligible patients |
Primary outcome
Actinic keratosis
Time frame: 8 weeks
Documentation of the course of actinic keratoses and skin findings during ambulant routine use of Picato®
Skindex-16
Time frame: 8 weeks
Patient' s quality of life during ambulant routine use of Picato®
Dosage of Picato®
Time frame: 8 weeks
Prescribed and applied dosages and adherence during ambulant routine use of Picato®
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Diepgen, Prof. Dr. med. principal investigator
University Hospital Heidelberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Actinic Keratosis, run by LEO Pharma at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Actinic keratosis (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2019.